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Abstract
Background: Peripheral intravenous device (IVD) complications were traditionally thought to be reduced by
limiting dwell time. Current recommendations are to resite IVDs by 96 hours with the exception of children and
patients with poor veins. Recent evidence suggests routine resite is unnecessary, at least if devices are inserted by
a specialised IV team. The aim of this study was to compare the impact of peripheral IVD ‘routine resite’ with
‘removal on clinical indication’ on IVD complications in a general hospital without an IV team.
Methods: A randomised, controlled trial was conducted in a regional teaching hospital. After ethics approval, 362
patients (603 IVDs) were randomised to have IVDs replaced on clinical indication (185 patients) or routine change
every 3 days (177 patients). IVDs were inserted and managed by the general hospital medical and nursing staff;
there was no IV team. The primary endpoint was a composite of IVD complications: phlebitis, infiltration, occlusion,
accidental removal, local infection, and device-related bloodstream infection.
Results: IVD complication rates were 68 per 1,000 IVD days (clinically indicated) and 66 per 1,000 IVD days (routine
replacement) (P = 0.86; HR 1.03; 95% CI, 0.74-1.43). Time to first complication per patient did not differ between
groups (KM with log rank, P = 0.53). There were no local infections or IVD-related bloodstream infections in either
group. IV therapy duration did not differ between groups (P = 0.22), but more (P = 0.004) IVDs were placed per
patient in the routine replacement (mean, 1.8) than the clinical indication group (mean, 1.5), with significantly
higher hospital costs per patient (P < 0.001).
Conclusions: Resite on clinical indication would allow one in two patients to have a single cannula per course of
IV treatment, as opposed to one in five patients managed with routine resite; overall complication rates appear
similar. Clinically indicated resite would achieve savings in equipment, staff time and patient discomfort. There is
growing evidence to support the extended use of peripheral IVDs with removal only on clinical indication.
Registration number: Australian New Zealand Clinical Trials Registry (ANZCTR) Number ACTRN12608000421336.
© 2010 Rickard et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
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in almost all cases a biochemical reaction to the mechan- 0.78-1.24) [15]. In addition, no clinically important or
ical irritation by the presence of the IVD and associated statistically significant differences were observed in the
infusate [3], although phlebitis symptoms such as secondary endpoints of phlebitis, infiltration, occlusion,
erythema may be misperceived as indicative of an infec- local infection or suspected bloodstream infection rates
tion. In fact, there is not a high correlation between phle- between study groups [15]. Another recent RCT in the
bitis and device infection, and the Centers for Disease ‘hospital in the home’ community setting also found no
Control (CDC) states that infection is rarely associated important clinical or statistically significant difference in
with peripheral, as opposed to central, venous devices phlebitis, occlusion or bloodstream infection rates in
[3,6,7]. Fluid infiltration or ‘tissuing’ of devices is another 316 patients when resite every 3 days was compared
common IVD complication which may also reflect the with clinically indicated resite [17]. A 2010 Cochrane
inflammatory (phlebitic) response of the vein, rather than Collaboration review concluded there was ‘no conclusive
simple misplacement of the device tip [8]. evidence of benefit’ of routine IVD resite and suggested
Early cohort studies noted an association between organisations could consider adopting a resite on clinical
increased device time in situ and phlebitis [9,10]. This indication policy [18]. There is growing evidence that
association was responded to with policies for routine routine IVD replacement may be ineffective, although
device removal. Recommended timelines for routine caution has been urged in light of the large number
resite have been extended over the past three decades (74% in both groups in the largest study to date) of
from 24, to 48, then to 72 hours. Currently, 72- to 96- reported devices inserted by a specialised IV team, a fac-
hour resite is recommended to reduce phlebitis by the tor known to reduce complications [19].
CDC’s 2002 Guidelines for the Prevention of Intravascu- Device insertion (and reinsertion) is unpleasant for
lar Device Infection, with the exemption that this is not patients, requires skilled and available clinical staff, and
required in children or those with poor veins [7]. Such has associated costs for the health sector. If replacement
policies cause increased workload in hospitals, where only on clinical indication is safe and effective, this
the task of removing and replacing well-functioning would have important benefits for patients and the
IVDs generally falls to busy nursing and junior medical health system. We report a RCT of 3-day routine IVD
staff. In addition, few patients welcome the prospect of resite versus clinically indicated replacement in a medi-
additional venipuncture. cal-surgical hospital where IVDs were inserted by the
Despite the general clinical acceptance of routine IVD general medical and nursing staff; the insitution did not
replacement as a phlebitis and infection prevention mea- have a specialised IV service.
sure, it has not been supported by recent data. It may be
that the risk of complications during the entire IVD Methods
treatment episode is similar, regardless of whether mul- Aim
tiple short-dwell or fewer longer-dwell IVDs are used The aim of the study was to compare the impact of 3-
over this time. Three small (n = 47-60) randomised, day routine resite, with clinically indicated resite, on
controlled trials (RCTs) suggested routine replacement peripheral IVD complications.
at 12, 24 or 48 hours may reduce phlebitis compared to
resite on clinical indication, although a systematic Design
review for the Swedish Council on Technology Assess- Open (nonblinded), parallel group RCT.
ment in Healthcare assessed these as low- to medium-
quality studies providing ‘limited scientific evidence’ Ethics
[11-14]. More recently, two well-conducted RCTs found The study was approved by the Tasmanian State Human
no evidence of effect when comparing IVD replacement Research Ethics Committee. Written informed consent
every 3 days with replacement only on clinical indica- was obtained prospectively from all participants.
tion for medical and surgical inpatients [15,16]. The lar-
gest of these studies reported findings from 755 general Setting and sample
medical and surgical patients with 1,428 IVDs and The study was undertaken at a large regional teaching
found a 5% difference in combined phlebitis and infiltra- hospital in Australia which functions as the tertiary refer-
tion rates per patient (38% clinically indicated resite, ral centre for the northern half of the State of Tasmania.
33% routine resite), suggesting a potential small clinical The hospital has more than 32,000 separations per
benefit of 3-day resite [15]. However, this difference was annum, with a spectrum of medical and surgical special-
not statistically significant (RR 1.15; 95% CI, 0.95-1.40) ties. Eligible patients were at least 18 years of age and
and disappeared when overall cannulation time was con- scheduled or expected to have a peripheral IVD indwel-
sidered (59.8/1,000 IVD days clinically indicated resite, ling for at least 4 days, and they gave written informed
60.9/1,000 IVD days routine resite; RR 0.98; 95% CI consent. Exclusion criteria were immunosuppression,
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current bloodstream infection or an IVD already in situ device insertion and removal were recorded along with
for >48 hours. IVDs were inserted and cared for by the the reason for device removal and any protocol devia-
general nursing and medical staff; there was no special IV tions. A full-time research nurse collected data from the
team or service. hospital chart and sought clarification from patients and
clinical staff if necessary. Microbiological investigations
Sample Size (device tip, blood cultures and site cultures) were per-
Sample size calculations were performed using PASS formed by the clinical staff on clinical suspicion of infec-
2008 (Version 8.0.8; Kaysville, UT) to detect a change in tion by the treating clinician. Demographic and clinical
rates by 30% (from 36% to 25%, two-tailed a = 0.05, data were collected on age, sex, diagnosis at hospital
90% power) on the basis of the complication rates of admission, phlebitis risk based on Tagar et al.’s classifi-
routinely resited IVs in a previous study [16]. Although cation (low/medium/high risk) [20], past history of phle-
this indicated that n = 378 per group (total 756) were bitis, any comorbidities requiring active medical
required, the study was ceased early (total n = 606 IVs) treatment (e.g., type 2 diabetes or congestive heart fail-
because all investigators left the employment of the ure), haemoglobin, concurrent infection at other sites,
institution. Consequently, study power was reduced, but antibiotic therapy, type of surgery, type of infusate and
remained over 80% (required minimum n = 282 per any additives (and their level of irritability), vein and
group). skin quality assessment, size of device, insertion site,
health professional inserting the device, and setting for
Recruitment insertion, presence of other vascular devices, wound
All adult patients admitted to the inpatient acute medi- drains and urinary catheters. Vein quality was assessed
cal and surgical wards of the study hospital were as good (vein easy to visualise and easy to palpate with
screened by a full-time research nurse. This excluded tourniquet on), fair (not easily visible but can palpate
paediatric, day-surgery, mental health, obstetric, critical with tourniquet), or poor (veins small, scarred or diffi-
care and dialysis units. cult to palpate with tourniquet; may require heat pack
to aid vasodilation). Skin quality was assessed as good
Study procedures (healthy, well hydrated, elastic), fair (mildly dehydrated,
Patients were randomly assigned (computer generated) reduced elasticity), or poor (papery, dehydrated, or
in a 1:1 allocation ratio to either the ‘routine replace- reduced elasticity).
ment’ (control) or ‘clinically indicated replacement’
(intervention) group. Assignment was concealed until Analytic Approach
randomisation by use of a telephone service. A tag was The primary outcome was a composite measure of any
placed on the insertion site indicating the study group. complication causing unplanned cannula removal prior
All devices for the patient were managed as per rando- to completion of IV treatment. The composite included
mised group. The intervention group did not have their phlebitis, infiltration, occlusion, accidental removal, local
IVD resited unless clinically indicated. This decision was infection, and IV device-related bloodstream infection
made by the treating clinician (not the investigators), (IVD-BSI). These were also analysed individually as sec-
who ordered IVD resite if the device failed or phlebitis ondary endpoints. A composite measure was chosen due
occurred and ongoing IV treatment was required. The to the low rates of these conditions individually and to
control group had a new device relocated to a different the assumption that they are comparable measures of
site by the general medical or nursing staff every 3 days. ‘infusion failure’; that is, the device can no longer be
Control devices could also be removed at any stage by used to deliver treatment. This approach has been used
the clinical staff if they were not required or if compli- in previous studies on the topic [15-17]. Phlebitis was
cations occurred. Clinical nursing and medical staff defined as two or more of pain, erythema, purulence,
undertook insertion and follow-up care of all IVDs as streak formation, or a palpable venous cord [3]. Local
per the CDC Guidelines [7]. infection IVD-BSI (bacteremia/fungemia with at least
Laboratory staff undertaking microbiological culture one positive blood culture obtained from a peripheral
assessments were blinded to the study group. Due to vein, clinical manifestations of infection, and no appar-
the nature of the intervention, patients, research, and ent source for the bloodstream infection (BSI) except
clinical staff were unable to be blinded. However, the the device with or without positive tip or entry site
investigators had no involvement in assessing or docu- swab culture) were defined using CDC criteria [7].
menting complications. Other secondary outcomes were time in situ (hours of
IVDs were assessed by the clinical nursing staff on catheterisation from insertion to removal, both per
each nursing shift for complications as part of standard patient and per device) [7]; IVDs per patient (number of
clinical practice in the hospital. Times and dates of peripheral devices inserted to complete the course of
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managed with routine resite (mean $55.42, SD $35.26) clinical indication would mean that one of every two
compared with resite on clinical indication (mean patients would need a single cannula to receive treat-
$43.35, SD $26.78). ment, whereas a 3-day change policy would result in
only one in five patients having this scenario, with the
Discussion rest requiring multiple cannulations and therefore addi-
The finding that 3-day routine resite was not an effec- tional pain and inconvenience.
tive intervention was consistent across the intention-to- The results are consistent with the findings of recent
treat primary analysis and the per protocol analysis. RCTs in both hospitals and the community that have
There remained no effect when events were expressed found no benefit in routinely resiting IVDs every 3 days
per patient or per 1,000 IVD days. Neither composite [15-17]. In these studies, many cannulae were inserted
nor individual complication rates differed between by an expert IVD team [15-17], which may have mini-
groups, and there were no cases of local or device- mised complications in both groups [19]. Our study
related bloodstream infection. It appears safe and practi- confirms and extends these findings into the general
cal to leave IVDs in situ as long as they are functioning medical/surgical setting without an IV team where IVDs
well and are still needed for clinical treatments. were inserted by a variety of nursing and medical staff.
All IVDs will fail eventually, but this study shows that Data from this study were included in a 2010 Cochrane
artificially shortening the lifespan of individual catheters Collaboration systematic review and meta-analysis on
does not reduce the overall complication rates over the the topic [18]. This review included six trials (n = 3,455)
course of therapy. Our results indicate that the average and reported no clinically important or statistically sig-
duration of IV therapy is 5-6 days and that many cathe- nificant difference in catheter-related bloodstream infec-
ters can remain complication-free for this period. If tion or phlebitis between IVDs that were routinely
catheters are not routinely resited, the median dwell resited (at 48-96 hours) or resited on clinical indication,
time would remain within the 72-96 hours recom- yet there were significantly lower costs in the group res-
mended by the CDC, but about 10% would remain ited on clinical indication [18].
in situ for longer (in this study up to 43 days with no The belief that routine resite of IVDs will prevent
complications). Our data show that a policy of resite on complications appears to stem from early observational
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studies that noted longer-dwelling IVDs had more com- designed cohort studies with modern catheter materials
plications than shorter-dwelling IVDs [9,10]. This is suggest that the daily risk of phlebitis is relatively stable
intuitively true, given, for example, that an IVD in situ after the first 24 or 48 hours [3,21,28-31]. The peak in
for 6 days has twice the time exposure of risk than an phlebitis between 24 and 48 hours is likely associated
IVD in situ for 3 days. However, this does not prove with the time taken by the body to mount a biological
that two sequentially inserted IVDs (in the same response after the instigation of therapy; those most
patient), both used for 3 days, have a combined lower likely to develop phlebitis will do so at this time.
risk over time than the 6-day dwell device. Indeed, this The results support the extension of the use of per-
and other recent trials strongly suggest that the risk for ipheral IVDs beyond the 72-96 hours currently recom-
the patient over the 6-day period is similar. Well- mended by the CDC [7]. There is incongruity in the
Figure 2 Kaplan-Meier survival curve of time to first intravenous device complication per patient (log rank, P = 0.53).
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Cite this article as: Rickard et al.: Routine resite of peripheral • Immediate publication on acceptance
intravenous devices every 3 days did not reduce complications
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compared with clinically indicated resite: a randomised controlled trial.
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